SORIN C5 SYSTEM MODEL 58-00-00
FDA 510(k) clearance K093882 · decided 2010-01-15
Clearance details
- K-number
- K093882
- Device name
- SORIN C5 SYSTEM MODEL 58-00-00
- Applicant
- Sorin Group Deutschland GmbH
- Decision
- Substantially Equivalent
- Date received
- 2009-12-18
- Decision date
- 2010-01-15
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DTQ
- Device class
- 2
- Regulation number
- 870.4220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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